ANDA Submissions Lagging As FY2023 Nears Its End
Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.
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Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.
Increases in the consumer price index helped drive some of the user fee increases that will take effect on 1 October, even though personnel costs declined in some FDA programs.
Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.